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Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971

Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971

Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..

Date : 27th February 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration

Overview: All life science businesses are required to maintain their Quality Management Syste..

Date : 21st September 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 30 Mins

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

Overview The landscape of computer system validation is undergoing a transformative shift wit..

Date : 30th April 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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